USPTO Patents Application 09879216

TED STATES PATENT AND TRADEMARK OFFICE

Richard, Robert

PATENT
Ser. No. 09/879,216
Atty. Docket N . 12013/59001

APPLICANT

SERIAL NO.

09/879,216

FILED

June 13, 2001

FOR

SUPERCRITICAL FLUIDS TO INFUSE THERAPEUTIC ON
MEDICAL DEVICE

GROUP ART UNIT

1762

Examiner

J. KOLB MICHENER

ASSISTANT COMMISSIONER FOR PATENTS
Washington, D.C. 20231

DECLARATION OF ROBERT E. RICHARD

I, Robert E. Richard, declare as follows:

1. I am the inventor of the above-referenced patent application currently pending
before the United States Patent and Trademark Office. I am informed that the application
currently contains claims 1-20, of which claims 16-20 stand withdrawn from consideration
following an election/restriction requirement. I am further informed that claims 1-2, 4-8, 10-
12 and 14-15 stand rejected as anticipated under 35 U.S.C. § 102(e) by U.S. Patent
Application Ser. No. 09/836,161 (U.S. Patent Application Publication No. U.S.
2002/0051845 Al) by Mehta, et cd. ("Mehta"), which has a filing date of April 17, 2001, and
that claims 3,7,9 and 13 stand rejected as obvious in view of Mehta.

2. I conceived of the subject matter recited in the pending claims of this application
prior to April 17, 2001. Evidence of this fact is shown in the attached Exhibit A, which was
written in 2000. Exhibit A is the invention disclosure document submitted to the Boston
Scientific Patent Review Board that describes concepts that lead to the filing of the invention
"SUPERCRITICAL FLUIDS TO INFUSE THERAPEUTIC ON MEDICAL DEVICE."

3. Exhibit A illustrates that conception of the subject matter recited in the pending
claims had occurred by 2000. For example, the date listed for the earliest known
documentation of the idea is in 2000. Further, I exercised diligence in reducing the invention
to practice, as substantially the entire focus of my employment at SCIMED Life Systems,
Inc. during this time was devoted to development of this invention. Reduction to practice of

PATENT
Ser.N . 09/879*216
Atty. Docket N . 12013/59001

the claimed subject matter occurred by 2000, as indicated by the reference in Exhibit A to a
bench test in 2000 that established the invention would work for its intended purpose beyond
the probability of failure.

4. AU my work to conceive and reduce to practice the subject matter claimed in the
above-referenced application was done in SCIMED Life Systems, Inc.'s Massachusetts
facilities.

7. As shown above, I had conceived and reduced to practice the subject matter
claimed in the pending application earlier than April 17, 2001.

I, Robert E. Richard, declare that all statements made of my own knowledge are true
and that all statements made on information and belief are believed to be true and that all
statements made herein are made with the knowledge that willful false statements and the like
are punishable by fine or imprisonment, or both (18 U.S.C. § 1001) and may jeopardize the
validity of the application or any patent issuing thereon.

Dated: June i_,20Q3

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Boston Scientific Corporation

Title of Idea: Process to Prepare Polymer/Therapeutic Agent Coated Stents
BSC Division/Technology: Molecular Interventions
Date you begin filling out this form:

Key words for search: Stent coatings, drugs, therapeutic agents, SIBS

Innovators):

Name (First, MI, Last)

(As you Eke it to appear on a Patent)

Work Location _
Home Address
Home Phone No*
Signature

Name (First, MI, Last)

(As you tike it to appear on a Patent)

Work Location
Home Address
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Signature

Name (First, MI, Last)

(As you Eke H to appear on a Patent)

Work Location
Home Address
Home Phone No.
Signature

Name (First, MI, Last)

(As you Eke It to appear on a Patent)

Work Location
Home Address
Home Phone No.
Signature

Robert E. Richard

Natick

257<

Work Phone Ext
Zip: 02093 Country:

3T ?yy-

State:

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Zip: Country:

Date:

State:

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Hp: Country:

Date:

State:

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Date:

Witnessed Signature
Position: JV,

Witnessed Signature: _
Position: Sat ^~^ f

_Work Phone Ext: ^X^f3

Boston Scientific Corporation

I. Briefly describe the current technology, devices, methods, etc that relates to your idea and any

disadvantages of the current technology. (Please attach any copies of articles, patents, drawings, pictures,
brochures, presentations, instructions for use, etc, describing the current technology.)

This disclosure relates to processes used to make drug (or other active agents like genes, DNA, proteins, etc.)
eluting stents. Current technology to produce such devices involves operations such as spraying a solution of
polymer plus drug onto the surface of a stent. A specific example of such a system is the paclitaxel(PTx)/SIBS
[SIBS = poly(styrene-isobutylene-styrene)] coated stent. This technology involves dissolving PTx and SIBS in
an organic solvent mixture (toluene and tetrahydrofuran) and spraying the solution onto stents. The
disadvantages to this system are that: (1) only a fraction of the PTx is eluted from the stent in practice, with the
remainder probably locked with the polymer permanantly. (2) Because the PTx is a highly potent drug, the
spraying operation is carried out in an expensive glove box apparatus. (3) The stents need to be precisely coated
to get the required drug loading and the operation is currently slow.

2. How does your idea address the disadvantages of the current technology? What problems are solved by
your idea? What is different from the current technology? What are the advantages of your idea?

The concept of swelling the polymer carrier coated onto a stent in a solution of drug in supercritical fluid could
allow more of the drug to be eluted from the coating in situ. This would allow a more accurate dose to be
administered and would also be more cost effective since the drug is very expensive and incorporating drug that-
never elutes from the stent is impractical.

If only the polymer carrier, for example SIBS, was to be spray coated onto the stent the conditions would not
need to be as rigorous or slow , since accuracy required for the current operation would not be needed. Also
since the drug is introduced in a second step (SCF swelling step) a large number of stents could potentially be
impregnated with drug at the same time (and with a more reproducible and precise dose from unit to unit).
Additionally, since the unsed drug would remain in the SCF and could be easily reclaimed. This operation would
also result in less wasted drug than a spraying operation where a significant portion of the drug spray does not
land on the stent).

3. Describe in detail the construction and operation of your device or method, specifically pointing out
advantages of your idea (e.g. speed, simplicity, repeatability, accuracy, lower cost, etc) Attach drawings
as appendices and refer to those drawings in the text A good technique is to first describe the structure of
the device and then its operation.

The preferred process would involve placing a number of stents that had been precoated with a polymer carrier
only (such as SIBS) in a chamber into which SCF could be generated. The SCF would b^ chosen such that the
drug was readily soluble in it (since paclitaxel is soluble in supercritical carbon dioxide it would be a good choice
for this drug). The SCF would also need to swell the polymer carrier sufficiently to allow the drug to imbibe into
it (since it has been determined that SIBS is swellable in supercritical carbon dioxide it would be a good choice
for this polymer carrier).

The advantages of this system are: (1) speed of operation since a number of stents could be impregnated with
drug simultaneously,(2)accuracy of drug dose since a large number of units are produced together and so that
process variation would be reduced, (3) lower cost since any drug not imbibed into the polymer could be readily
reclaimed and reused for subsequent process runs, (4) the ability to better control- the percentage of drug that
ultimately elutes from the stent. r '

Alternatives: Describe any alternative designs, methods f construction r operation or manufacturing of
the above device or method. For example, are there alternative materials that may be cheaper or that may
provide different features such as stiffness? Are there other products or devices that may incorporate the
idea? What other features might the idea incorporate? Put yourself in the competitor's shoes~ How
w uldyou take advantage of this idea but avoid the device or method?

The primary product system addressed by this disclosure is the SIBS/pTx coated stent Variations could include
any agent (DNA, genes, proteins, or any other therapeutic agent like NO, enzymes, etc..) impregnated into any
substrate which swells or can be permeated by a supercritical fluid. Altghough the present disclosure used
supercritical carbon dioxide, other SCFs could be used depending on the chemical nature of the carrier or the
drug

What BSC products are affected? What competitor products are affected?

The primary product affected would be the paclitaxel eluting stent that is currently being developed. Other
products that could potentially benefit from this technology would include PCTA balloons or any other product
currently used to deliver a therapeutic agent to a specific site in the body.

Will the idea be manufactured outside the US? If so, where? Please list any foreign countries you believe
BSC should seek patent protection in and why. For example, a competitor manufactures in France or the
market potential is highest in Japan.

The product could be manufactured in Ireland. Patent protection in Europe and Japan should be considered

1 . Documentation of Idea:

a. Date of earliest known documentation of idea: (Please attach a copy if available*)

Lab Notebook No*: 391 PageNo(s).: 1

If different, date of first known drawings:

b. Who has custody of drawings?:

c. Date of first known internal disclosure:
To whom: Marlene Schwarz

a.
b.

2. Prototype:

Start date of first known prototype/model build: (add any description of the first or other prototypes that may be helpful)
TBD

Date of first known test of idea: (add any description of test results that may be helpful)
Bench, Animal or Clinical?: Bench

Kara Brennan, Phasex Corp.

Please list any witnesses who saw the prototype.
Project phase:

a. What is the current proj

b. Product to be released

c. Engineering Project Ni

*ojc£^nhase
[umber: 1

(concept, development or scale-up?): Concept

Release date:

101404

4. Disclosure outside of BSC:

yes

Has the idea been disclosed outside of BSC?:
If NO:

Is a future disclosure planned?: Where?:

When?:

(If less than 2 months away, please notify the on-site patent representative immediately.)
If YES:

Was the disclosure written or oral?: Both ,

To whom was the disclosure made and why?: ^^HHHH^^^H^^Vof Phasex Corp., They possess

tn^Cf^Sftnolog^eereWWrot the concept

By whom?: Bob Richard Is a written confidentiality agreement (CDA) in place?: Yes

Prototype External to BSC:

Has a prototype or model been used or shipped external to BSC?:

No

No

b. Has the idea been incorporated in a commercially released product?:

c. If NO:

When is a prototype expected to be used or shipped external to BSC?:

When is a product expected to be commercially released?: TBD

(If less than 2 months away, please notify the on-site patent representative immediately.)

1Q01

6. Please list any potentially relevant publications, presentations, patents or patent applications or other
descriptions of which you are aware:

None

7.

Name any key physicians who might be r are interested in the idea.

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